FDA.reportPublic FDA data

COMPACTCATH Extension Tube

Primary DI
10852141007847
Brand
COMPACTCATH Extension Tube
Company
COMPACTCATH, INC.
Model
1903-1832
Catalog number
1903-1832
Device description
The CompactCath extension tube is connect with CompactCath Lubricated Intermittent Urinary Catheter when needed.
Published
2021-02-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KNXCollector, Urine, (And Accessories) For Indwelling Catheter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KNXCollector, Urine, (And Accessories) For Indwelling CatheterGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10852141007847PrimaryGS10
00852141007840Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085214100784710852141007847
00852141007840008521410078408521410078400852141007840

GMDN Terms#

Term, Definition table
TermDefinition
Urinary catheter/drainage bag connection facilitatorA non-sterile device intended to provide a patient or healthcare provider a means of rapid and leak-proof bag exchange during replacement of a urine bag that connects to an in situ urinary catheter. It is typically made of plastic and consists of two separate blades, each with a scissors-like handle and which terminates distally in a half-cylinder channel. The distal ends of the blades are inserted into the stretchable connector of the urine bag to form a full-cylinder channel through which the proximal end of an indwelling ureteral or urinary condom catheter is inserted to form a connection with the bag, after which the blades are removed. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge16French
Length16Inch

Contacts#

Phone, Email table
PhoneEmail
+1 (888) 933-2284support@compactcath.com

Regulatory Flags#

DUNS number
054765780
Device count
25
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10810053920036OneCath Hydro2031-16142031-16142021-10-23
10810053920043OneCath Hydro2031-08122031-08122021-10-23
10810053920081OneCath Hydro2032-16142032-16142021-10-23
00810053920039OneCath Hydro2031-16142031-16142021-10-23
00810053920046OneCath Hydro2031-08122031-08122021-10-23
00810053920084OneCath Hydro2032-16142032-16142021-10-23
00852141007468OneCath201-1612 (30) 1612 (30 pack)2021-09-25
00852141007475OneCath201-1614 (30)1614(30)2021-09-25
00852141007925OneCath Lubricated2041-16142041-16142021-09-25
00852141007949OneCath Lubricated2042-16142042-16142021-09-25
00852141007079OneCath201-1612 (30) 1612 (30 pack)2021-09-25
00852141007109OneCath201-1614 (30)1614(30)2021-09-25
00852141007871OneCath Lubricated2041-16142041-16142021-09-25
00852141007895OneCath Lubricated2042-16142042-16142021-09-25
00852141007840COMPACTCATH Extension Tube1903-18321903-18322021-02-02
10852141007724COMPACTCATH - Lite1011-16161011-16162019-09-01
10852141007731COMPACTCATH - Lite1012-16161012-16162019-09-01
00852141007383COMPACTCATH - Lite1011-16121011-16122019-08-01
00852141007321COMPACTCATH - Lite1012-16141012-16142019-07-05
00852141007307COMPACTCATH - Lite1002-16141002-16142019-04-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10192253068603DoverCardinal Health 200, LLCKNX2026-01-16
10192253068719DoverCardinal Health 200, LLCKNX2026-01-16
10192253068726DoverCardinal Health 200, LLCKNX2026-01-16
10192253068733DoverCardinal Health 200, LLCKNX2026-01-16
10192253067989DoverCardinal Health 200, LLCKNX2026-01-15
10192253068016DoverCardinal Health 200, LLCKNX2026-01-15
10192253068214DoverCardinal Health 200, LLCKNX2026-01-15
10840330701799ProCureTwin Med, LLCKNX2025-05-31
10840330701805ProCureTwin Med, LLCKNX2025-05-31
10192253027792DoverCardinal Health 200, LLCKNX2025-04-01
10192253028232DoverCardinal Health 200, LLCKNX2025-04-01
10192253032161DoverCardinal Health 200, LLCKNX2025-04-01
20192253030058DoverCardinal Health 200, LLCKNX2025-04-01
10192253027945DoverCardinal Health 200, LLCKNX2025-03-20
10192253028461DoverCardinal Health 200, LLCKNX2024-12-20
10192253028522DoverCardinal Health 200, LLCKNX2024-12-20
10192253028539DoverCardinal Health 200, LLCKNX2024-12-20
10192253028546DoverCardinal Health 200, LLCKNX2024-12-20
10192253028560DoverCardinal Health 200, LLCKNX2024-12-20
10192253031126DoverCardinal Health 200, LLCKNX2024-12-20
10192253027938DoverCardinal Health 200, LLCKNX2024-11-04
10192253028287DoverCardinal Health 200, LLCKNX2024-11-04
10192253028492DoverCardinal Health 200, LLCKNX2024-11-04
10192253031447DoverCardinal Health 200, LLCKNX2024-11-04
10192253028195DoverCardinal Health 200, LLCKNX2024-10-14
10192253028201DoverCardinal Health 200, LLCKNX2024-10-14
10192253028263DoverCardinal Health 200, LLCKNX2024-10-14
10192253028386DoverCardinal Health 200, LLCKNX2024-10-14
10192253031379DoverCardinal Health 200, LLCKNX2024-10-14
10195327301927Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KNX2023-02-05